- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00086502
Pioglitazone Add-on Study in Patients With Type 2 Diabetes Mellitus
A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Addition of MK0431 to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Pioglitazone Therapy
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patient has type 2 diabetes mellitus (T2DM)
- Patient is 18 years of age (or older)
- Patient is not pregnant or breast-feeding and does not plan to become pregnant for the duration of the study and poststudy follow-up period
Exclusion Criteria:
- Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis
- Patient required insulin within the prior 8 weeks
- Patient is on a weight loss program and is not in the maintenance phase
- Patient started on a weight loss medication (e.g., orlistat or sibutramine) within the prior 8 weeks
- Patient is on or likely to require treatment with treatment with immunosuppressive agents (e.g., cyclosporin, methotrexate)
- Patient has cirrhosis, active liver disease (other than fatty liver) or symptomatic gallbladder disease
- Patient has chronic myopathy, or a progressive neurological or neuromuscular disorder (e.g., multiple sclerosis or polymyositis)
- Patient has any of the following disorders within the past 6 months:
Acute coronary syndrome (e.g., MI or unstable angina), Coronary artery intervention, Stroke or transient ischemic neurological disorder.
- Patient has new or worsening signs or symptoms of coronary heart disease within the past 3 months
- Patient has severe peripheral vascular disease
- Patient has congestive heart failure
- Patient is HIV positive
- Patient has a clinically important hematological disorder (e.g., aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
- Patient has a history of neoplastic disease
- Patient has a history of alcohol or drug abuse within the past 3 years
- Patient has viral hepatitis (hepatitis B or C)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Placebo komparator: Placebo
|
Pioglitazone 30 mg or 45 mg once daily, Visit 2 through Visit 8
Andre navne:
Metformin rescue for patients meeting pre-specified glycemic criteria. Metformin 500 mg,once daily, Visit 4 through Visit 8
Placebo (to match Sitagliptin 100 mg) once daily, from Visit 4 through Visit 8. Day 1 through Week 24
|
Aktiv komparator: Sitagliptin 100 mg
|
Sitagliptin 100 mg once daily, from Visit 4 through Visit 8. Day 1 through week 24
Andre navne:
Pioglitazone 30 mg or 45 mg once daily, Visit 2 through Visit 8
Andre navne:
Metformin rescue for patients meeting pre-specified glycemic criteria. Metformin 500 mg,once daily, Visit 4 through Visit 8 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24
Tidsramme: Baseline and week 24
|
HbA1c is measured as a percent.
Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.
|
Baseline and week 24
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24
Tidsramme: Baseline and week 24
|
Change from baseline at Week 24 is defined as Week 24 minus Week 0.
|
Baseline and week 24
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Glukosemetabolismeforstyrrelser
- Metaboliske sygdomme
- Sygdomme i det endokrine system
- Diabetes mellitus
- Diabetes mellitus, type 2
- Hypoglykæmiske midler
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Proteasehæmmere
- Inkretiner
- Dipeptidyl-Peptidase IV-hæmmere
- Metformin
- Pioglitazon
- Sitagliptin fosfat
Andre undersøgelses-id-numre
- 0431-019
- Formally-A0604T2DPT
- 2006_410
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